In Europe, during 2021, have been authorised 79 new drugs, of which 61 contain new substances 
active (25 orphan drugs for the treatment of rare diseases), 6 biosimilar drugs and 12 equivalents. Among the new drugs authorized by the European Medicines Agency (EMA), the primacy of antineoplastic and immunomodulatory drugs (40,5%) remains, intended for the treatment of autoimmune diseases and some types of solid tumors (such as lung cancer, of the breast and uterus) and blood (such as myeloma, lymphoma and leukemia), followed by systemic anti-infectives (12,6%), nervous system (7,6%) and digestive drugs, and of metabolism (7,6%); lower percentages concern new medicines belonging to other ATC categories.
These are some of the information contained in the 4th edition of the Report "Horizon Scanning: scenario of incoming medicines", published by the Italian Medicines Agency on the institutional portal. The Report aims to provide information on new medicines and new therapies, which received a positive opinion from the EMA in 2021 or which may have it in the following years.
Among the orphan medicinal products that have received a positive opinion from the EMA, two are drugs for advanced therapies, specifically gene therapies: Abecma, for the treatment of adults with relapsed and refractory multiple myeloma, and Skysona, for the treatment of cerebral adrenoleukodystrophy early.
On the data available at the time of drafting the Report, for theyear 2022 an opinion from the EMA is expected for 96 new medicines, with a preponderance of anti-cancer drugs, followed by a significant share of medicines for the nervous and sensory systems, immunosuppressants and immunostimulants, and medicines for the digestive system and metabolism. Lastly, of the 29 orphan medicinal products currently under evaluation, 7 are medicinal products for advanced therapies.
The publication of the Report is part of the Horizon Scanning activities of AIFA, aimed at early identification and evaluation of new medicines and new therapeutic indications of already authorized medicines, which will be able to expand the treatment options available to doctors and patients by filling the needs of health not yet satisfied.
AIFA – Published on: 24 March 2022
Horizon Scanning Report – Scenario of Incoming Medicines – 2022
